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Analgesic Effect of Acupuncture for Patients With Rib Fractures

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ClinicalTrials.gov Identifier: NCT03822273
Recruitment Status : Recruiting
First Posted : January 30, 2019
Last Update Posted : January 30, 2019
Sponsor:
Information provided by (Responsible Party):
Chun-Ting Liu, Chang Gung Memorial Hospital

Brief Summary:
Traumatic rib fractures are common, resulting from significant forces impacting on the chest, and are associated with significant morbidity and mortality. Acute pain management in inpatients with traumatic rib fractures has been highly emphasized by practitioners. Inappropriate analgesia may cause respiratory complications, including pneumonia, atelectasis, acute respiratory distress syndrome, and prolonged hospital stay. These may be prevented or reduced by good analgesic therapy. This study is aimed to investigate the analgesic effect of acupuncture on traumatic rib fractures.

Condition or disease Intervention/treatment Phase
Rib Fractures Acute Pain Analgesia Procedure: Traditional acupuncture (TA) Procedure: Laser acupuncture (LA) Procedure: Sham laser acupuncture (SLA) Not Applicable

Detailed Description:
This open-label, randomized controlled trial will involve 150 patients who have traumatic rib fractures. Subjects are randomly assigned to acupuncture group, laser acupuncture group or sham laser acupuncture group with a 1:1:1 ratio. The intervention will be performed on the consecutive three day after allocation. Bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for each group. The traditional acupuncture group will be performed by inserting needles to a depth of 15-35 mm and last for 15 min. The laser acupuncture will be performed with the gallium aluminum arsenide LaserPen, which delivered 0.375 J of energy at each of the acupoints. Subjects in the control group underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the laser acupuncture group.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  1. Acupuncture group
  2. Laser acupuncture group
  3. Sham laser acupuncture group
Masking: Single (Outcomes Assessor)
Masking Description: All the patients are told that they will receive one kind of acupuncture treatment in addition to the original oral analgesics and assess the efficacy of acupuncture. The patients are randomly assigned to three groups after providing written informed consent, without being mentioned which kind of acupuncture treatment is applied as control. Patients are not blinded to TA or LA treatment, but they can be blinded to LA or SLA treatment. The outcome assessor is also blinded to the group assignments and is trained to apply the pain scales and conduct physical tests. To avoid unblinding of the assessment of outcomes, the patients are instructed not to discuss any aspect related to their treatment with the assessor.
Primary Purpose: Treatment
Official Title: Analgesic Effect of Acupuncture for Patients With Rib Fractures: an Open-label, Randomized-controlled Trial
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : February 1, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Traditional acupuncture (TA)
The subject will receive real acupuncture treatment once per day for 3 days after enrollment.
Procedure: Traditional acupuncture (TA)

Procedure: real acupuncture.

Eight disposable, single use, sterilized, stainless steel needles are inserted at each session, and the bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for acupuncture treatment. The acupuncture needles are to be inserted to a depth of 15-35 mm. All needles are rotated manually at least once at each session to elicit needle sensation (De qi). The needle retention time is 15 min.


Active Comparator: Laser acupuncture (LA)
The subject will receive laser acupuncture treatment once per day for 3 days after enrollment.
Procedure: Laser acupuncture (LA)

Procedure: laser acupuncture.

Participants allocated to the LA group receive laser acupuncture treatment at the same acupoints used in acupuncture group. The laser acupuncture therapy will be performed with the gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5 Hz, B2: 1199 Hz, B3: 2398 Hz, B4: 4776 Hz, B5: 9552 Hz, B6: 19,104 Hz, and B7: 38,208 Hz]; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany). The laser will be applied to each point for 5 seconds, which delivered 0.375 J of energy at each of the acupoints: LI4 (Hegu, B3), SJ6 (Zhigou, B3), ST36 (Zusanli, B2) and GB34 (Yanglingquan, B2).


Placebo Comparator: Sham laser acupuncture (SLA)
The subject will receive sham laser acupuncture treatment once per day for 3 days after enrollment.
Procedure: Sham laser acupuncture (SLA)

Procedure: sham laser acupuncture.

Subjects in the control group receive sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the LA group.





Primary Outcome Measures :
  1. Efficacy of pain relief [ Time Frame: The NRS will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. Primary outcome is the change of NRS score on DAY 1 pretreatment and DAY 3 post treatment. ]
    Maximal pain intensity (Numerical Rating Scale; NRS: 0‑10) evaluated by participants themselves during deep breathing, coughing, and turning over in bed.


Secondary Outcome Measures :
  1. Sustained maximal inspiration lung volumes [ Time Frame: The sustained maximal inspiration lung volumes will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. ]
    Sustained maximal inspiration lung volumes

  2. Number of cases with pulmonary complications [ Time Frame: Follow-up for one month ]
    Pulmonary complications including pneumonia, atelectasis, pleural effusion, acute respiratory distress syndrome, and respiratory failure.

  3. Saliva cortisol level [ Time Frame: The saliva cortisol level will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. ]
    Saliva cortisol level

  4. Heart rate variation [ Time Frame: The heart rate variation will be assessed at Day 1, Day 2 and DAY 3 pretreatment and posttreatment in the morning (8:00-10:00) and evening (15:00-17:00), respectively. ]
    Heart rate variation

  5. The dose of narcotic and non-narcotic analgesics used [ Time Frame: Record the medication use for 2 weeks after participant enrolled ]
    Record the use of narcotic and non narcotic analgesics based on chart reviews. Narcotic drugs include codeine, tramadol, and morphine. Non narcotic drugs include acetaminophen, ibuprofen, diclofenac, ketoprofen, mefenamic acid, and parecoxib.



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Ages Eligible for Study:   20 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Chest trauma
  • Presence of one or more, unilateral or bilateral rib fractures diagnosed with chest X‑ray
  • Maximal rib pain score of more than 5 obtained using the numerical rating scale (NRS: 0‑10)
  • Ability to describe the sites of pain and evaluate the pain intensity accurately

Exclusion Criteria:

  • Unable to describe the sites of pain and evaluate the pain intensity accurately
  • There are open wounds on the sites of acupuncture points
  • Severe multiple trauma or any poorly controlled diseases such as atelectasis, pneumonia, or other infectious diseases, immune system dysfunction, bleeding tendency, psychiatric disorders, and skin problems
  • Receive surgical management of rib fractures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03822273


Contacts
Contact: Chun-Ting Liu, MD +886-7-7317123 ext 2334 juntin0214@gmail.com

Locations
Taiwan
Kaohsiung Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 833
Contact: Chun-Ting Liu, MD    +886-7-7317123 ext 2334    juntin0214@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital
Investigators
Principal Investigator: Chun-Ting Liu, MD Chang Gung Memorial Hospital

Responsible Party: Chun-Ting Liu, Attending doctor, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT03822273     History of Changes
Other Study ID Numbers: 201701455A3
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chun-Ting Liu, Chang Gung Memorial Hospital:
Traumatic rib fractures
Acupuncture
Analgesia

Additional relevant MeSH terms:
Fractures, Bone
Acute Pain
Rib Fractures
Wounds and Injuries
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Thoracic Injuries
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs